Vascular Solutions, Inc. recalls Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model nu

Recalled March 27, 2013 · FDA recall Z-0955-2013 · Vascular Solutions

Hazard

Risk that air may be introduced into the device which may lead to an air embolism. · FDA Class I

Units

79,869

Sold at

Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI, and countries of GREECE, DENMARK, AUSTRIA, UNITED KINGDOM, SWITZERLAND, IRELAND, INDIA, TURKEY, POLAND, HUNGARY, ITALY, EGYPT, KOREA, PORTUGAL HONG KONG, GERMANY, SPAIN, MEXICO, SWEDEN, NORWAY SLOVENIA, NETHERLANDS, and BELGIUM.

Description

Risk that air may be introduced into the device which may lead to an air embolism.

Product

Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.

Manufacturer(s)

Vascular Solutions, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →